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FDA clears Medtronic's CoreValve Evolut R System

Jun. 23, 2015 9:52 AM ETMedtronic plc (MDT) StockMDTBy: Douglas W. House, SA News Editor3 Comments
  • The FDA approves Medtronic's (MDT -0.1%) CoreValve Evolut R System for transcatheter aortic valve replacement (TAVR) in patients with severe aortic stenosis (narrowing) who are at high/extreme risk for surgery. It is the first self-expanding recapturable transcatheter heart valve available in the U.S.
  • TAVR is a minimally invasive surgical procedure to repair an old or damaged aortic valve. Instead of opening up the chest and replacing the defective valve, the replacement is wedged in the valve's place via a catheter. When the new valve is expanded it pushes the old valve leaflets out of the way and assumes the job of regulating blood flow.

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